2024-518759-45-00RecruitingPhase 3
Evaluation of the efficacy and safety of prolonged-release budesonide in children with primary IgA nephropathy.
SABINE - The efficacy and Safety of delayed-release Budesonide in children with primary IgA nephropathy - a multicenter, interventional phase III, randomized, placebo-controlled, double-blind study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Mar 2026
Brief summary (registry, in English)
1. Proving that Budesonide DR in combination with ACEI is more effective than placebo in reducing proteinuria. 2. To assess whether treatment with Budesonide DR is better than treatment with Prednisone in reducing proteinuria in the study population.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 7 Oct 2025
- Lead sponsor
- Medical University Of Warsaw
- Diseases
- IgA nephropathy
- EU CT number
- 2024-518759-45-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 8-17 years with primary IgA nephropathy confirmed by kidney biopsy and protein in the urine. It compares budesonide DR with placebo and with prednisone.
- Age
- 8 to 17 years
- Sex
- Boys and girls can both join.
- Disease stage
- Primary IgA nephropathy diagnosed on kidney biopsy, with proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests.
- Earlier treatment
- No treatment, or treatment with ACEI/ARB. Any steroid or immunosuppressive treatment must have ended at least 2 months earlier.
- Biomarker or test result
- Proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests. A negative pregnancy test is needed at the start of treatment.
Main reasons for not taking part
- Secondary forms of IgA nephropathy, such as IgA vasculitis or Crohn's disease
- Pregnancy or breastfeeding
- Rapidly progressive glomerulonephritis in the course of IgAN
- GFR < 60 ml/min according to Schwartz at randomization
- Steroid or immunosuppressive treatment now or less than 2 months before screening
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently or less than 2 months before the screenig used systemic steroid therapy or immunosuppressive treatment such as: azathioprine, mycophenolate mofetil, cyclophosphamide, tacrolimus, cyclosporine A
Other illness
- secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease
- chronic diseases that, in the opinion of the researcher, may affect the course of treatment, e.g. tuberculosis
- severe heart disease
- active peptic ulcer disease of the stomach and/or duodenum
- history of prednisone intolerance
Lab values
- GFR < 60 ml/min according to Schwartz at the time of randomization
Other
- pregnancy or breastfeeding
- rapidly progressive glomerulonephritis in the course of IgAN
- cataract, glaucoma
Who the study is looking for
- obtaining consent from the parent/legal guardian and the patient to participate in the study
- age 8-17 years
- primary IgA nephropathy diagnosed on kidney biopsy
- no treatment or treatment with ACEI/ARB
- steroid treatment or immunosuppressive treatment completed at least 2 months previously
- proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests
- negative pregnancy test result (urine platelet) at the time of qualification to start treatment
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku | Bialystok | Poland | Recruiting |
| Uniwersytecki Szpital Dzieciecy W Krakowie | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Recruiting |
| Uniwersytecki Szpital Dziecięcy w Lublinie | Lublin | Poland | Recruiting |
| Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu | Poznan | Poland | Recruiting |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun | Poland | Recruiting |
| Medical University of Warsaw | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.